ACE393-103 Vaccination Challenge Study (ACE393-103VC)

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A Randomized, Double-Blind, Placebo Controlled Vaccination-Challenge Study of ACE393 to Determine Efficacy Against the Symptoms of Moderate to Severe Campylobacter Jejuni Infection in Normal Healthy Volunteers

Brief Summary

The purpose of this study is to determine whether ACE393 vaccination can protect against Campylobacteriosis in a challenge model.

Detailed Description

This study is a randomized, double blind, parallel group, placebo controlled study, in which subjects, with no evidence of prior C.jejuni infections or immunity, will be vaccinated with ACE393, a protein sub-unit vaccine, or placebo, and then subsequently challenged with C.jejuni. The study will include vaccination of approximately 72 subjects, with the aim of challenging a total of 60 subjects. ACE393 or placebo will be administered twice by intramuscular injection on an outpatient basis, three weeks apart and then the subjects will be challenged three weeks later with C.jejuni. During the inpatient monitoring period, volunteers will be evaluated daily for safety, clinical signs and symptoms of disease and stool microbiology). Criteria for early institution of oral hydration, intravenous fluids, serum electrolyte monitoring, blood cultures, and/or antibiotics are predefined. All volunteers will receive antibiotic therapy 6 days after challenge (unless treated early). Discharge criteria are predefined. Post-discharge follow-up will further monitor safety, confirm C .jejuni eradication after antibiotic therapy, and assess immunologic response.

Placebo 500 micrograms Alhydrogel as intra muscular injection at day 0 and day 21

Other Name: Campylobacter jejuni

Study Arms

Experimental: 1

vaccination with ACE393 followed by challenge with campylobacter jejuni

Intervention: Biological: ACE393

Placebo Comparator: 2

Placebo vaccination followed by challenge with campylobacter jejuni

Intervention: Biological: Placebo vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Unknown status

Estimated Enrollment ICMJE

72

Estimated Completion Date

July 2009

Estimated Primary Completion Date

March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion criteria (selected):

Male or female between 18 and 50 years of age.

General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by the principal investigator or the principal investigator in consultation with the medical monitor and sponsor.